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Racial and Genetic Biomarkers of Response in Tissue Samples From Patients With Endometrial Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2015 by Gynecologic Oncology Group
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01198171
First received: September 8, 2010
Last updated: May 27, 2015
Last verified: May 2015
  Purpose
This research study is studying racial and genetic biomarkers of response in tissue samples from patients with endometrial cancer. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. DNA analysis of tumor tissue may also help doctors predict how well patients will respond to treatment.

Condition Intervention
Stage I Uterine Corpus Cancer
Stage II Uterine Corpus Cancer
Stage III Uterine Corpus Cancer
Stage IV Uterine Corpus Cancer
Other: Laboratory Biomarker Analysis
Other: Study of Socioeconomic and Demographic Variables

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: The Relationship of Racial Genetic Admixture With Endometrial Cancer Outcomes

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Clinicopathologic and demographic characteristics: characteristics: self-reported race, stage, age, race, parity, body-mass index, stage, grade, depth of invasion, lymph-vascular space invasion, and metastasis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Proportion of genetic background that is of African-American descent [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Racial genetic admixture score, summarized by race and other clinicopathologic variables [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 243
Study Start Date: January 2100
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Basic science (DNA analysis)
DNA from archived frozen normal tissue samples is genotyped for the ancestry informative markers. Clinicopathological and demographic characteristics associated with each sample are also collected.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Study of Socioeconomic and Demographic Variables

Detailed Description:

PRIMARY OBJECTIVES:

I. To identify racial categorization as the proportion of genetic background of African-American or European-American women with endometrioid endometrial cancer (EEC).

II. To evaluate the association of racial genetic admixture with clinicopathologic variables and outcomes.

SECONDARY OBJECTIVES:

I. To compare the concordance between racial genetic admixture and self-designated race categorization.

OUTLINE: This is a multicenter study. Patients are stratified by race (African-American vs European-American) and disease stage (I vs II vs III vs IV).

DNA from archived frozen normal tissue samples is genotyped for the ancestry informative markers. Clinicopathological and demographic characteristics associated with each sample are also collected.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with endometrial cancer
Criteria

Inclusion Criteria:

  • Histologically confirmed endometrial cancer

    • Stage I-IV disease regardless of grade
    • Underwent surgical staging including hysterectomy, bilateral oophorectomy, washings, and pelvic lymphadenectomy
  • Eligible and evaluated on GOG-0210 clinical trial, a Molecular Staging Study in Endometrial Cancer
  • Available frozen or formalin-fixed and paraffin-embedded normal tissue that is free of tumor cells and yields sufficient high-quality normal DNA for testing
  • Consented their specimens and clinical data to be collected and used in future studies
  • Self-declared African-American or Caucasian race
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198171

Locations
United States, Pennsylvania
Gynecologic Oncology Group Active, not recruiting
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Rodney Rocconi Gynecologic Oncology Group
  More Information

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01198171     History of Changes
Other Study ID Numbers: GOG-8022  NCI-2011-02867  CDR0000684547  GOG-8022  GOG-8022  P50CA134254  R01CA071754  R21CA133295  U10CA027469  U10CA037517 
Study First Received: September 8, 2010
Last Updated: May 27, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on December 09, 2016